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From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes

Por: Montreuil · T. · Skinner · J. · Humez · L. · Gratton · C. · Herba · C. M. · Cote · S. M.
Introduction

Parental psychological challenges and poor well-being are key factors in shaping both the quality of parent-child interactions and child development. Specifically, maternal psychological distress is a central determinant of child development. Elevated levels of distress in mothers are associated with poorer child cognitive, behavioural and social-emotional outcomes, with effects persisting into adolescence and adulthood. While this highlights the critical importance of early prevention and intervention efforts to support parents, postpartum mental healthcare remains limited, despite ongoing and evident needs.

Methods and analysis

This protocol outlines a 2-year longitudinal follow-up study investigating the impact of a secondary perinatal programme (ie, Toi, Moi, Bébé), completed by mothers during pregnancy, and its impact on children’s cognitive and social-emotional functioning at 24 and 48 months. Further, the study aims to explore whether maternal self-efficacy and emotion regulation may serve as potential mediators or moderators of the relationship between programme participation and child development outcomes. The research aims to leverage the Toi, Moi, Bébé programme, by recruiting mother-child dyads (n=250) in which the mothers participated in the programme during pregnancy. Mothers were randomly assigned to complete the parenting well-being intervention either independently or with added telephone support. Participants who consent will be invited to take part in a two-wave follow-up at 24 months (T1) and 48 months postpartum (T2). At both time points, mothers will complete demographic questionnaires and standardised measures assessing maternal well-being (Generalised Anxiety Disorder-7, Edinburgh Postnatal Depression Scale and Perceived Stress Scale), child cognitive functioning (Ages and Stages Questionnaire-3 and MacArthur-Bates Communicative Development Inventory), child social-emotional functioning (Ages and Stages Questionnaire, Social Emotional—second Edition-2 and Child Behaviour Checklist for Ages 1.5–5), maternal emotion regulation (Cognitive Emotion Regulation Questionnaire) and maternal self-efficacy (Parental Cognitions and Conduct Towards the Infant Scale & Me as a Parent Scale). Parents’ perceptions of their parenting experience will be measured using the Parental Reflective Functioning Questionnaire. Mother-child interaction, parenting quality and cognitive stimulation in the home environment will be measured using a brief virtual interview (StimQ2-Toddler) and a naturalistic observation assessment (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes). Using RStudio, linear mixed models will be used to assess the impact of the intervention (online intervention only vs only with telephone support) on child cognitive and social-emotional development at T1 and T2. In parallel, separate models will be conducted to examine associations between maternal emotion regulation and self-efficacy on the child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine potential moderating effects of child sex and group assignment on the associations between maternal emotion regulation and self-efficacy and child developmental (cognitive and socioemotional) outcomes, using causal inference models.

Ethics and dissemination

The current study has been registered, reviewed and approved (MP-37-2025-10894) by the Research Institute of the McGill University Health Centre Research Ethics Board. Findings from this research will be disseminated through peer-reviewed open access publications, and presentations at national and international conferences.

Trial registration number

NCT05110456.

Effectiveness and cost-effectiveness of a 9 week multi-component cycling programme versus an existing single cycling training session: protocol for the Cycle Nation Communities randomised controlled trial

Por: Lawlor · E. R. · Gabler Trisotti · M. F. · McIntosh · E. · McConnachie · A. · Gill · J. M. R. · Gray · C. M.
Introduction

Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

Methods and analysis

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethics and dissemination

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

Trial registration number

NCT07005674.

Delivering hospital care at home in a Dutch Tertiary University Hospital: protocol for a prospective feasibility cohort study evaluating a Virtual Ward for early discharge of inpatients

Por: van Herwerden · M. C. · Scholte · N. T. B. · Mkrtchjan · A. · Feyz · L. · Mol · A. P. · Aitken · J. · de Boer · R. A. · Chandoesing · P. P. · Gommers · D. A. M. P. J. · De Haan · B. · Den Hoed · C. M. · van den Hoogen · M. W. F. · Peeters · R. P. · Wlazlo · N. · Van Der Boon · R. M.
Introduction

Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

Methods and analysis

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

Ethics and dissemination

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

Trial registration number

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

Patiromer utility as an adjunct treatment in patients needing urgent hyperkalaemia management (PLATINUM): a randomised controlled trial in the emergency department

Por: Rafique · Z. · Safdar · B. · Duanmu · Y. · Boone · S. · Meltzer · A. · Bischof · J. J. · Robinson · D. · Budden · J. · Budd · J. · Quinn · C. M. · Milliet · C. · Singer · A. J. · Soto · K. · Peacock · F.
Objectives

Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.

Design

A prospective, randomised, double-blind, placebo-controlled study.

Setting

16 ED sites across the USA.

Participants

Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.

Interventions

Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.

Primary and secondary outcome measures

The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.

Results

The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).

Conclusions

No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.

Trial registration number

NCT04443608.

Analgesic efficacy of peri-operative methadone in orthopaedic surgery: protocol for a systematic review of randomised controlled trials

Por: Evaldsson · B. B. · Nygaard · K. H. · Petersen · S. R. · Moos · C. M. · Stroem · T. · Specht · K. · Schonnemann · J. O.
Introduction

Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.

Methods and analysis

This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).

Ethics and dissemination

As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42025616291.

Dietary practices among antenatal women in Sri Lanka: prevalence and associated factors

Objective

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

Design

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Results

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

Conclusions

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

Mental Health First Aid training for Chile and Argentina: protocol for a cluster randomised controlled trial

Por: Agrest · M. · Encina-Zuniga · E. · Ardila-Gomez · S. · Fernandez · M. A. · Gabriel · R. · Bargamian · J. · Alvarado · R. · Morgan · A. J. · Kelly · C. M. · Reavley · N.
Introduction

Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

Methods and analysis

The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics and dissemination

Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

Trial registration number

ISRCTN63724445.

Linking everyday physical activity and capacity tests using wearable and mobile technologies in older adults and cardiac cohorts: protocol for a pilot observational study

Por: Caramaschi · S. · Maus · B. · Olsson · C. M. · Smedberg · D. · Kristen · H. · Whitehead · M. · Orchard · E. · Salvi · D.
Introduction

This study investigates the potential of digital health technologies (DHTs), such as wearable devices and smartphones, to complement traditional submaximal functional capacity tests, such as the 6 min walk test (6MWT) and the timed up and go test (TUG). While these traditional tests are widely used due to their simplicity and relevance to daily living activities, they have limitations, including infrequent administration and the need for clinical observation. DHT offers continuous, real-world monitoring, which may accurately reflect patients’ health status and effectively inform clinical decisions. However, there is a need to establish the validity of the data and metrics computed through DHT and understand patient perspectives on using such technology.

Methods and analysis

This is an observational pilot study (Synergy Digital Health study) that aims at linking wearable data with traditional test outcomes and assessing participants’ acceptance and usage of such DHT. A cohort of 30 cardiovascular patients from Oxford University Hospitals, UK, and 30 community-dwelling elderly people from social centres in Helsingborg, Sweden, will use wearable devices for 2 months in free-living conditions, they will fill out technology acceptance questionnaires (AQs), have baseline assessments and perform physical tests such as the 6MWT and TUG using the Mobistudy smartphone app. Subgroups will participate in codesign workshops to identify experience-based design recommendations for the technology. Quantitative and qualitative methods will be adopted to analyse the collected data.

Ethics and dissemination

The study protocol received ethical approval in Sweden from the Etikprövningsmyndigheten (2024-04886-01) and in the UK from the National Health Service (NHS) Research Ethics Committees (Iras project ID: 340870), in accordance with local regulations. All participants are asked for written informed consent. The results of the study will be shared via scientific journals and conferences.

Connecting families--randomised controlled trial of poverty screening and financial support navigation for families of young children in primary care: an internal pilot study informed protocol

Por: Bayoumi · I. · Parkin · P. C. · Tabassum · F. · Johnson · C. · Sherwood · M. · Mitchell · M. · Birken · C. S. · Bloch · G. · Carsley · S. · Cole · M. · Green · M. · Keown-Stoneman · C. D. G. · Maguire · J. L. · Purkey · E. · van den Heuvel · M. · Weir · S. · Wong · P. · Borkhoff · C. M.
Introduction

Poverty can have profound negative impacts on parent, child and family health. Primary care providers are in a unique position to address child poverty. Some team-based models have integrated community support workers (CSWs) for social service system navigation assistance. The overall aim of this study is to rigorously test a poverty reduction intervention (navigation of financial supports) embedded in primary care. The primary objective is to compare parenting stress between CSW-supported, structured review of financial supports and social system navigation (intervention) and receipt of written summary of local resources (usual care).

Methods and analysis

This is a multisite pragmatic superiority randomised controlled trial with a 1:1 allocation to the CSW-supported social system navigation versus no navigation. Parent–child dyads (80 parents of children aged Do you ever have difficulty making ends meet at the end of the month?’) will be recruited during a scheduled health supervision visit from primary care practices in Kingston, Ontario. Intervention group participants will have a structured review of financial supports with a trained CSW and will meet up to 6 times over 6 months. Outcomes are measured at baseline, 6 months and 12 months after randomisation. The primary outcome is the Parenting Stress Index Fourth Edition Short Form (PSI-4-SF) total score at 6 months. Secondary outcomes include household income, food insecurity, parent mental health (depression and anxiety) and child health. An internal pilot study was used to obtain more reliable estimates of the SD of PSI-4-SF at 6 months to recalculate the sample size (if needed) and assess randomisation and completion rates. Qualitative interviews conducted 9 months after enrolment explore parent experiences with the CSW intervention.

Ethics and dissemination

Research ethics approval by Queen’s University Health Sciences REB. Results will be shared with the College of Family Physicians of Canada, the Ontario SPOR SUPPORT Unit and academic forums.

Trial registration number

Connecting Families (Registered 12 October 2021 at www.clinicaltrials.gov; NCT05091957).

Functional decline and social support in older patients during hospitalisation: a cross-sectional study of some determinants of care in a poor resource setting, Southeast Nigeria

Por: Anyigor-Ogah · C. S. · Ekechi · A. N. · Chukwuonye · M. E. · Nweke · I. C. · Idika · I. M. · Ovuoba · C. M.
Introduction

There is a high level of older people neglect in Nigeria, especially in the rural setting, and they did not receive much attention in terms of their overall health and well-being. Government social interventions are usually geared towards the children, adolescents, pregnant women and lactating mothers. Evaluating the level of functional decline and social support among these groups and how it affects their overall well-being will enable policy formulations geared towards holistic care for them. This study aimed to determine the level of functional dependence in some basic activities of daily living (ADLs: mobility, dressing, grasp and bathing) and social support in older people to enhance evidence-based advocacy to all stakeholders in older people care.

Methods

This was a hospital-based cross-sectional study of 160 (75 males and 85 females) older people aged 65–98 years selected through systematic random sampling. The 2 test, t-test and logistic regression were used for analysis.

Results

The response rate was 100%. The mean age of male respondents was 76.31±8.34 years and that of the female respondents was 76.87±7.47 years. A statistically significant association was found between age >75 years, absence of a spouse, low education level and functional dependence in all ADLs studied. Although age independently predicted dependence in all studied ADLs, except dressing and grasp, marital status predicted dependence in dressing and bathing, and availability of care also predicted dependence in mobility.

Conclusion

Age is an independent risk factor for functional dependence in mobility and bathing, and marital status independently predicted dependence in dressing and bathing. Not receiving care also independently predicted dependence in mobility. Thus, improvements in the biopsychosocial, biomedical and economic well-being of older people will ameliorate the impact of poor care on functional status and ADLs.

Introducing an integrated maternity care pathway for women with a history of small-for-gestational-age: Evaluation of its effect on care process and clinical outcomes

by Anne C. M. Hermans, Julia Spaan, Marieke A.A. Hermus, Amber M. Hietkamp, Jantien Visser, Arie Franx, Jacoba van der Kooy

Introduction

This study focusses on the implementation of an integrated care pathway for women with SGA in their obstetric history that pursues value-based healthcare. This study aims to 1) Determine whether the integrated care pathway led to a reduction in the number of antenatal secondary care consultations, as an indicator of care efficacy, and 2) compare clinical outcomes for women with a history of SGA before and after implementation of the integrated care pathway.

Methods

Retrospective cohort study including data from pregnant women with a history of SGA within integrated maternity care organisation Annature, 2017–2020. Intervention was an integrated care pathway (2018). Pre- and post-intervention periods were compared assessing prenatal secondary care consultations, place and mode of delivery, and perinatal outcomes.

Results

The implementation of the care pathway for pregnant women with a history of SGA led to a reduction in mean number of prenatal secondary care consultations per pregnancy from 11 in 2017–5 in 2020, and fewer inductions of labour (78 (34.2%) vs 127 (26.8%), p = 0.045). Additionally, the number of births in primary care increased (35 (15.4%) vs 136 (28.8%), p  Conclusion

The implementation of the care pathway for pregnant women with a history of SGA resulted in a reduction in prenatal secondary care consultations and fewer inductions of labour. Additionally, the number of births in primary care increased, with no significant adverse impact on neonatal outcomes in the post-intervention period compared to the pre-intervention period.

Online Remote Behavioural Intervention for Tics (ORBIT-UK): protocol of a single cohort usability study

Por: Hastings · O. · Brown · B. J. · Prentice · K.-M. · Babbage · C. M. · Davies · E. B. · Kilgariff · J. · Murphy · T. · McGarry · G. · Guo · B. · Greenhalgh · C. · Hollis · C. · Hall · C. L.
Introduction

Tourette syndrome is a common, disabling childhood-onset condition. Exposure and response prevention (ERP) is an effective treatment for tics, yet access remains limited due to a shortage of trained therapists and uneven geographical distribution of services. The ORBIT trial demonstrated that internet-delivered ERP is both clinically and cost-effective, but was developed on a university research platform, not suitable for widescale roll-out. To enable adoption by the National Health Service (NHS) in England, ORBIT has been redeveloped on an NHS compliant platform. This study will evaluate the usability, acceptability and preliminary outcomes of ORBIT on the new platform within an NHS tic disorder service.

Methods and analysis

This single-cohort usability study will recruit 20 children and young people (aged 9–17) with tics and their chosen supporters (parents/carers). Participants will receive a 10-week online ERP intervention supported by trained coaches. Outcomes include uptake, adherence, system usability, satisfaction and clinical measures such as the Yale Global Tic Severity Scale, Parent Tic Questionnaire and Goal-Based Outcomes. Qualitative feedback will be collected via semi-structured exit interviews. Usability metrics and adverse events will be monitored throughout.

Ethics and dissemination

The study has received ethical approval from North West Greater Manchester Research Ethics Committee (ref: 25/NW/0107). The findings from the study will inform future NHS adoption. The results will be submitted for publication in peer-reviewed journals.

Trial registration number

ISRCTN82718960. Registered 10 July 2025. https://doi.org/10.1186/ISRCTN82718960

Critical appraisal and comparison of clinical practice guideline recommendations for the treatment of anaemia in chronic kidney disease: a systematic review protocol

Por: Agnelli · J. C. M. · Costa · W. R. d. · Iwami · R. S. · Franques · R. T. · Lopes · L. C. · Barberato-Filho · S. · Bergamaschi · C. d. C.
Introduction

In chronic kidney disease (CKD), anaemia develops and evolves as kidney dysfunction progresses. The treatment of anaemia is described in clinical practice guidelines (CPGs), which are designed to report the most relevant evidence for clinical practice in disease management. This study will analyse CPGs for transparency, methodological quality and quality of recommendations for their implementation over time, and also compare recommendations for the treatment of anaemia outlined in these documents.

Methods and analysis

CPGs will be identified by conducting a systematic search of the data sources CINAHL, Embase, MEDLINE, Scielo, Scopus, ProQuest, Trip Database, Virtual Health Library, Web of Science, and guidelines on websites, published between January 2009 and December 2025. Three reviewers will, independently, evaluate the methodological quality of the guidelines using the Appraisal of Guidelines for REsearch and Evaluation II (AGREE-II) tool and the quality of recommendations using the AGREE – Recommendations Excellence tool. The treatment recommendations for anaemia in CKD will be summarised and compared. Results will be presented in tables and descriptive statistics will be compiled for all domains of the tools.

Ethics and dissemination

This is a literature-based study and, therefore, no ethical approval will be required. Results of the study can be submitted for publication in high-impact, peer-reviewed scientific journals, and also presented at national and international conferences.

Prospero registration number

CRD42024629656.

Digital support for chronic dyspnoea management in primary care: protocol for the BREATHE (Breathlessness Rapid Evaluation and Therapy) cluster randomised controlled trial

Por: Martin · A. · Sunjaya · A. P. · Giskes · K. · McKeough · Z. · Hespe · C. M. · Arnott · C. · Billot · L. · Campain · A. · Scowcroft · C. P. · Atkins · E. R. · Jan · S. · Scott · H. A. · Chua · A.-V. · Jenkins · C. R. · on behalf of the BREATHE Investigators · Peiris · Marks · Praveen
Introduction

Chronic dyspnoea is a prevalent symptom, and primary care is ideally placed to identify and manage it. However, chronic dyspnoea is under-reported by patients and can be a diagnostic dilemma for practitioners. A fully automated system of patient screening, coupled with a clinical decision support system (CDSS) that uses a validated and evidence-based dyspnoea algorithm, may improve detection, diagnosis and management of the condition. There is currently no CDSS validated for chronic dyspnoea diagnosis and management in primary care in Australia. The objectives of this study are to assess the clinical impact of a CDSS for chronic dyspnoea in primary care. We hypothesise that the use of the CDSS will lead to a clinically significant improvement in patient-reported dyspnoea scores, reduced time to diagnosis and healthcare costs at 12 months compared with standard care.

Methods and analysis

The BREATHE study is an open-label, cluster-randomised controlled trial of standard of care compared with a CDSS. General practices (n=40) in metropolitan, regional/rural and rural/remote settings will be recruited and randomised equally to pre-screening for chronic dyspnoea and usual standard-of-care management or pre-screening and CDSS-guided management. The CDSS includes an algorithm derived from a robust data and clinical knowledge model and incorporates evidence-based recommendations for the assessment and management of chronic dyspnoea. It is integrated into general practice medical software systems, fitting in the workflow of general practitioners (GPs). Eligible patients will be ≥18 years old and will have previously consented to receive SMS communication from their practice. In-scope patients will receive an automated text message prior to their GP appointment and will be screened for chronic dyspnoea (≥4 weeks). Patients identified with chronic dyspnoea will be invited to participate in the BREATHE study and followed up for 12 months. The primary outcome is improvement in the Dyspnoea-12 (D-12) score from baseline to 12 months, measured by the Dyspnoea-12 (D-12) questionnaire. Secondary outcomes include disease-specific questionnaires to assess changes in clinical outcomes, time to final diagnosis, quality of life, healthcare utilisation and costs incurred to patients.

Trial registration number

The trial is registered at ANZCTR (ACTRN12624001451594). ANZCTR is a primary registry that meets the requirements of the ICMJE and is listed on the ICTRP Registry Network.

Ethics and dissemination

The study protocol has been approved by the University of New South Wales Human Research Ethics Committee (HREC) (iRECS6645) and complies with the National Health and Medical Research Council ethical guidelines. Participating practices and each GP will provide written, informed consent. All patients being screened will provide electronic informed consent. Results of the study will be disseminated through various forums, including peer-reviewed publications and presentation at national and international conferences. Following the study, participating practices will be provided with a summary of the findings of the study, together with a full copy of any publications and a plain language statement for participants, which will be made available in the practice reception area.

Implementation strategies for the WHO Safe Childbirth Checklist: a scoping review

Por: Gama · Z. A. d. S. · Semrau · K. E. A. · Rosendo · T. M. S. d. S. · Freitas · M. R. d. · Saraiva · C. O. P. d. O. · Westgard · C. M. · Mita · C. · Tuller · D. E. · Freitas · K. d. M. S. · Molina · R. L.
Background

The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.

Objectives

To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.

Eligibility criteria

We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.

Sources of evidence

We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.

Charting methods

This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).

Results

34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.

Conclusions

SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.

Registration

Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.

Cardiac rehabilitation in atrial fibrillation: a protocol for a Danish survey and registry-based study (PRIME-AF)

Por: Elnegaard · C. M. · Borregaard · B. · Risom · S. S. · Tveskov · C. · Bech · M. · von Bornemann Hjelmborg · J. · Eilso · J. · Hedegaard · A. M. · Stege Bojer · A. · Darkner · S. · Albertsen · A. E. · Joensen · A. M. · Brandes · A. · Zwisler · A.-D.
Introduction

Atrial fibrillation (AF) is a growing public health concern associated with significant morbidity, mortality and impaired quality of life. Despite evidence supporting cardiac rehabilitation (CR) as part of secondary prevention in AF care, referral rates remain low, and the extent of CR needs in this population is unknown. This protocol outlines a nationwide survey-based and registry-based study aiming to: i) describe CR needs among individuals with AF and ii) assess eligibility and acceptance of referral to specific CR components based on individual patient preferences and their overlap with identified needs.

Methods and analysis

This cross-sectional study includes three phases: 1) identification of the study population using Danish national registries; 2) electronic survey distribution to individuals with a first-time AF diagnosis in 2023–2024 and 3) registry data enrichment of the entire population. The survey includes validated patient-reported outcome measures aligned with a newly developed Needs Assessment Model, supplemented by items on patient preferences for CR components. Data are analysed descriptively and using correlation analysis.

Ethics and dissemination

Participants are informed of the study purpose, data protection and their rights before providing informed consent through survey participation. The study follows the Declaration of Helsinki and Danish ethical standards. Findings are disseminated via scientific journals, conferences, a cross-sectoral stakeholder workshop and public outreach activities.

Trial registration number

NCT06772207.

Epidemiology and disease burden of connective tissue disease-associated interstitial lung disease (CTD-ILD) in Asia: a systematic review and meta-analysis protocol

Por: Chua · F. · Subramaniam · S. · Lai · W. H. · Tan · S. H. · Yean · H. R. A. · Kho · S. S. · Yew · J. S. Y. · Hong · H. C. · Ng · C. C. M. · Sirol Aflah · S. S. · Mohd Zaidi · N. A. · Ong · V. H. · Chai · G. T. · Ang · S. H. · Maamor · H. · Muhamad · N. A.
Introduction

Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.

Methods and analysis

This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.

PROSPERO registration number

The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).

Association between weather, air quality and asthma-related emergency department visits: a retrospective time-series study in Singapore

Por: Toh · M. R. · Wen · X. · Ng · G. X. Z. · Fun · A. Q. R. · Youxin · P. · Fong · L. · Wu · J. T. · Ong · M. · Matchar · D. B. · Tan · N. C. · Loo · C. M. · Sheikh · A. · Koh · M. S. · Lam · S. W.
Objectives

To evaluate the association between asthma-related emergency department (ED) visits and weather, air quality, monsoons, haze and cultural festivals in Singapore.

Design

Retrospective cohort study.

Setting

A public healthcare cluster that covers 20% of the nation’s adult asthma population.

Participants

2617 adult patients accounting for 5337 asthma ED visits between 2016 and 2024.

Primary and secondary outcome measures

Temperature, rainfall, wet bulb temperature (WBT), wind speed and Pollution Standards Index (PSI) were correlated with asthma ED counts at 0–7 day lags. Associations between ED visits and monsoons, transboundary haze and cultural festivals were evaluated using one-way analysis of variance. Weekly seasonal ARIMA models with exogenous regressors were fitted, incorporating PSI as a covariate and adjusting for demographic, clinical and socioeconomic factors.

Results

Asthma ED visits were positively correlated with PSI (lag 0: r=0.142; 95% CI 0.107 to 0.178) and inversely correlated with rainfall (lag 3: r=–0.062; 95% CI –0.099 to –0.026) and WBT (lag 1: r=–0.067; 95% CI –0.104 to –0.031). Wind speed (lag 2: r=–0.049; 95% CI –0.086 to –0.013) and ambient temperature (lag 6: r=–0.045; 95% CI –0.081 to –0.008) showed weaker inverse associations. Mean PSI was higher during haze (82.67 vs 51.46, p

Conclusions

PSI–ED association peaked on the same day of exposure but was no longer significant after adjusting for demographic and clinical factors. Pollution-linked festivals, transboundary haze and the Northeast monsoon were associated with increased asthma ED visits

Association between carotid-femoral pulse wave velocity and cardiovascular disease in individuals with moderate blood pressure: a systematic review and individual participant meta-analysis

Por: Pavey · H. · Wood · A. · Mceniery · C. M. · AlGhatrif · M. · Arshi · B. · Brunner · E. · Chen · C.-H. · Cheng · H.-M. · Hansen · T. W. · Ikram · M. K. · Kavousi · M. · Kuh · D. · Kuipers · A. L. · Lakatta · E. G. · Linneberg · A. · Mattace Raso · F. · Mitchell · G. F. · Maldonado · J. · Ne
Objectives

The predictive value of carotid-femoral pulse wave velocity (cfPWV) for cardiovascular (CV) events in individuals with blood pressure (BP) 120–159/80–99 mm Hg, where more accurate risk stratification has the greatest clinical effect, is unknown. This study aims to determine whether cfPWV improves the prediction of CV events beyond traditional risk factors in individuals with moderate BP.

Design

A systematic review and meta-analysis.

Data sources

PubMed and EMBASE were searched through April 2023.

Eligibility criteria

We included prospective, population-based cohort studies with ≥1 year follow-up that directly measured cfPWV as an index of arterial stiffness and reported incident CV disease (CVD), atherosclerotic CVD (ASCVD), coronary heart disease, stroke or all-cause mortality outcomes.

Data extraction and synthesis

Individual participant data from 11 cohorts (n=15 987) were harmonised and analysed using two-stage random-effects meta-analysis. Incremental predictive and clinical utility analyses compared 10-year risk models with and without cfPWV.

Results

There were 1279 first atherosclerotic CV events over a median follow-up of 9.9 years. A 1-SD increase in loge(cfPWV) was associated with a 1.21-fold (95% CI 1.08 to 1.36) increase in risk of ASCVD. Adding cfPWV to traditional risk factors improved ASCVD prediction: change in discrimination (C-index): 0.0048 (95% CI 0.0002 to 0.0094), p=0.041. In hypothetical populations of 100 000 individuals with moderate BP, cfPWV-guided treatment could reduce event rates by 2.7% and 3.1% under European and US guidelines, respectively.

Conclusions

Adding cfPWV to traditional CV risk factors may improve the prediction and classification of first CV events in individuals with moderate BP. Additional screening with cfPWV could enhance risk stratification for antihypertensive treatment initiations.

How Government Policies and Organisational and Sectoral Circumstances Influence Nurse Practitioner and Physician Assistant Employment and Training: A Realist Analysis Using Surveys

ABSTRACT

Aims

To explain how government policies affected decision-making on Nurse Practitioner and Physician Assistant employment and training within Dutch healthcare organisations, and how organisational and sectoral circumstances were influential.

Design

An online, cross-sectional survey study.

Methods

A literature- and interview-based program theory was tested using surveys. Respondents from hospital care, (nursing) home care, primary care, and intellectual disability services were recruited using convenience sampling. Data analysis used descriptive statistics and inferential tests. Open-ended responses were analysed using thematic synthesis techniques. Survey results were clustered to assess verification, falsification, or refinement of program theory elements.

Results

A total of 568 experts in hiring and training healthcare professionals participated. Respondents indicated that most government policies promoted employment and training. Organisational and sectoral circumstances caused significant variations in Nurse Practitioner and Physician Assistant deployment across healthcare sectors, shaping how decision-makers interpreted and acted on government policies. Specific circumstances within primary care hampered deployment.

Conclusion

Government policies stimulated training and employment by: (1) removing practice restrictions (scope of practice expansion, legal acknowledgment), (2) facilitating cost-effective training and deployment (training grants, billing options), (3) providing sectoral knowledge on deployment, training, and healthcare outcomes (funding research and a sectoral knowledge center), and (4) establishing sectoral agreements (on apprenticeships). Organisational and sectoral circumstances significantly influenced outcomes. Key circumstances included flanking policies, stakeholder support, labor market capacity, healthcare demand, organisational resources and aims, and type of decision-makers (medical doctor or manager/director). Familiarity with the professions stimulated deployment.

Impact and Implications

The refined and verified program theory supports designing effective skill-mix policies and facilitating Nurse Practitioner and Physician Assistant employment and training. Tailoring skill-mix policies can optimise outcomes. This offers opportunities for governments, healthcare funders, organisations, and professionals to contribute to healthcare quality, cost efficiency, and patient satisfaction.

Patient or Public Contribution

Healthcare professionals were part of the study population.

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